Lymphoma, Non-Hodgkin
Conditions
Interventions
investigational material(s)
Generic name etc : Copanlisib (BAY 80-6946)
INN of investigational material : Copanlisib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration fo
Sponsors
Bayer Yakuhin, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed diagnosis of CD20 positive Indolent non-Hodgkins lymphoma (iNHL) with histological subtype limited to: - Follicular lymphoma grade1-2-3a -Small lymphocytic lymphoma with absolute lymphocyte count = 2 x upper limit of normal (ULN) and positive immunofixation test . - Male or female patients >= 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status == 45% - Patients must either have had a treatment-free interval of at least 12 months after completion of the last rituximab-containing treatment OR be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments or unwillingness to receive chemotherapy.
Exclusion criteria
Exclusion criteria: - Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia - Progression free interval or treatment free interval of less than 12 months since the last rituximab containing treatment (including rituximab maintenance). For patients considered unfit to receive chemotherapy: progression free interval or treatment free interval of less than 6 months since the last rituximab containing treatment (including rituximab maintenance), as assessed by the investigator - History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function - Known lymphomatous involvement of the central nervous system - Patients with HbA1c > 8.5% at Screening - Known history of human immunodeficiency virus (HIV) infection - Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA - Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors. - Prior treatment with copanlisib - Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression free survival (PFS) 59 months | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Objective tumor response - Duration of response (DOR) - Complete response - Time to progression (TTP) - Overall survival (OS) - Time to deterioration in DRS-P of at least 3 points as measured by the FLymSI-18 (Lymphoma Symptom Index -18) questionnaire - Time to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, will be evaluated for patients with a baseline DRS-P score of 30 points or less - Number of participants with adverse events as a measure of safety and tolerability | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed